Remove Biotechnology Remove Health Data Remove Healthcare Remove Regulations
article thumbnail

Governing Health Data for Research, Development, and Innovation: The Missteps of the European Health Data Space Proposal

Bill Of Health

By Enrique Santamaría Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union.

article thumbnail

Protecting the Consumer at the Heart of DTC Precision Medicine

Bill Of Health

Namely, legal protections concerning personal health data may not apply when the entity offering the service is decidedly not a “provider.” To illustrate the issue, consider that the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) expressly covers genetic information as a form of health data.

article thumbnail

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill Of Health

Introduction: A Fragmented AI in Healthcare Regulatory Landscape In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. B y Suzan Slijpen, Mauritz Kop & I. Glenn Cohen 1.